Device recalls
Recall records from FDA, newest initiation date first.
Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.
Data as of , the FDA export date. FDA medical device recall database
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-0410-2022 | Class II | Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit intended to be used to... | Becton Dickinson & Co | PZG | |
| Z-0409-2022 | Class II | Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract... | Becton Dickinson & Co | PZG | |
| Z-0408-2022 | Class II | Malosa Core Phaco Pack 2- Medical Refractive Kit intended to be used to aid in cataract... | Becton Dickinson & Co | PZG | |
| Z-0407-2022 | Class II | Malosa Core Phaco Pack 1-Medical Cataract Kit intended to be used to aid in cataract... | Becton Dickinson & Co | PZG | |
| Z-0406-2022 | Class II | Malosa Core Suface Treatment Pack -Medical Corneal Kit intended to be used to aid in... | Becton Dickinson & Co | PZG | |
| Z-0405-2022 | Class II | Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid in cataract... | Becton Dickinson & Co | PZG | |
| Z-0828-2022 | Class II | cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number... | Roche Molecular Systems Inc | OOI | |
| Z-0420-2022 | Class II | Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM | Abbott Medical | DYB | |
| Z-0482-2022 | Class II | Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and... | Ohio Medical LLC | BTA | |
| Z-0337-2022 | Class I | Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75... | Datascope Corp. | DSP | |
| Z-0336-2022 | Class I | Cardiosave Hybrid IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31... | Datascope Corp. | DSP | |
| Z-0471-2022 | Class II | Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC... | Philips North America LLC | OWB | |
| Z-0415-2022 | Class II | TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and... | Acclarent Inc | PGW | |
| Z-0547-2022 | Class II | ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B | Siemens Medical Solutions USA, Inc. | IYN | |
| Z-0357-2022 | Class II | Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing... | Philips North America LLC | OWB | |
| Z-0356-2022 | Class II | BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and... | Philips North America LLC | OWB | |
| Z-0355-2022 | Class II | BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and... | Philips North America LLC | OWB | |
| Z-0388-2022 | Class II | Flexor Check-Flo Introducer Ansel Modification Model Number... | Cook Incorporated | DYB | |
| Z-0387-2022 | Class II | Flexor Check-Flo Introducer Ansel Modification Model Number... | Cook Incorporated | DYB | |
| Z-0447-2022 | Class II | Invacare AVIVA Storm RX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model... | Invacare GmbH | ITI | |
| Z-0446-2022 | Class II | Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers... | Invacare GmbH | ITI | |
| Z-0445-2022 | Class II | Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers... | Invacare GmbH | ITI | |
| Z-0332-2022 | Class II | Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery... | Medtronic, Inc. | LFL | |
| Z-0383-2022 | Class I | Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or... | Medtronic Navigation, Inc | HAW | |
| Z-0334-2022 | Class II | O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions... | Orchestrate Orthodontic Technologies, Inc. | PNN | |
| Z-0527-2022 | Class II | PIVO Blood Collection Device 20G, REF: 202-0005 | Becton Dickinson Infusion Therapy Systems Inc. | JKA | |
| Z-0454-2022 | Class III | iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System... | LTS Therapy Systems, LLC | EGJ | |
| Z-0399-2022 | Class II | SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825 | Siemens Healthcare Diagnostics Inc. | CHH | |
| Z-0895-2022 | Class II | Amplatzer Steerable Delivery Sheath | Abbott Medical | DQY | |
| Z-0417-2022 | Class II | Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide... | Medtronic Navigation, Inc | HAW | |
| Z-0422-2022 | Class II | RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25... | bioMerieux, Inc. | JSS | |
| Z-0413-2022 | Class II | Torosa Saline-Filled Testicular Prosthesis (Size Small) | MEDLINE INDUSTRIES, LP - Northfield | FHW | |
| Z-0380-2022 | Class II | Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101... | Ossur Americas | IQK | |
| Z-0455-2022 | Class II | QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223 | Qiagen | QLT | |
| Z-0391-2022 | Class II | Medical Device Identification Cards associated with Astra XT DR Implantable pulse... | Medtronic, Inc. | NVZ | |
| Z-0390-2022 | Class II | Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN... | Medtronic, Inc. | NVY | |
| Z-0381-2022 | Class II | Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers... | Boston Scientific Corporation | MCX | |
| Z-0825-2022 | Class II | DigniCap Delta Scalp Cooling System, Product Number: 900-1001, Labeling: The DigniCap... | Dignitana AB | PMC | |
| Z-0524-2022 | Class II | GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi" | GE Healthcare | IYO | |
| Z-0523-2022 | Class II | GE Vscan Extend, being sold as "Vscan Extend Sector USB" | GE Healthcare | IYO | |
| Z-0522-2022 | Class II | GE Vscan Extend, being sold as "Vscan Extend Sector DICOM" | GE Healthcare | IYO | |
| Z-0521-2022 | Class II | GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi" | GE Healthcare | IYO | |
| Z-0520-2022 | Class II | GE Vscan Extend, being sold as "Vscan Extend Dual USB" | GE Healthcare | IYO | |
| Z-0519-2022 | Class II | GE Vscan Extend, being sold as "Vscan Extend Dual DICOM" | GE Healthcare | IYO | |
| Z-0518-2022 | Class II | GE Vscan Extend, being sold as "Vscan Extend Console" | GE Healthcare | IYO | |
| Z-0411-2022 | Class II | regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit... | ROi CPS LLC | MLS | |
| Z-0421-2022 | Class II | FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test | Migo Trading LLC | QKP | |
| Z-0316-2022 | Class II | INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS | Wright Medical Technology Inc | HSN | |
| Z-0315-2022 | Class II | INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS | Wright Medical Technology Inc | HSN | |
| Z-0353-2022 | Class I | Puritan Bennett 980 Series Ventilator, 980X3JADIJJ | Medtronic, Inc. | CBK |